Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Overview
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
Full Title of Study: “Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2006
Interventions
- Drug: MALG
- 30 minute application
Arms, Groups and Cohorts
- Experimental: 1
- MALG
Clinical Trial Outcome Measures
Primary Measures
- Change in cholinesterase level
- Time Frame: 1 day
Secondary Measures
- Clinical evidence of cholinesterase inhibition
- Time Frame: 1 day
- Local tolerability
- Time Frame: 1 day
- Cure of head lice 14 days after last treatment
- Time Frame: 2 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Confirmed active head lice infestation – Parent or guardian must be able to apply treatment Exclusion Criteria:
- Allergy to pediculicides or hair care products – Scalp conditions other than head lice – Previous head lice treatment within the past 4 weeks – Current antibiotic treatment
Gender Eligibility: All
Minimum Age: 6 Months
Maximum Age: 24 Months
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Taro Pharmaceuticals USA
- Provider of Information About this Clinical Study
- Medical Director, Taro Pharmaceuticals USA
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